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Completed

NCT Number: NCT03595618

A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis

This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Achieve Clinical Research, LLC, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male participants or female participants of non-childbearing potential and not breastfeeding.
  • Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2.
  • Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.
  • History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month.
  • Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.
  • Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics

Exclusion criteria

  • Severe clinical knee malalignment according to the investigator.
  • Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side).
  • Knee prosthesis already foreseen within the study period (whichever side).
  • Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side).
  • Previous osteotomy on the inferior limbs (whichever side).
  • Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.
  • Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.
  • Other pathologies affecting the target knee.
  • Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.

Treatment and study plan

GLPG1972

Drug

Film-coated tablets of GLPG1972 for oral use.

Placebo

Drug

Film-coated tablets of matching placebo for oral use.

Primary outcomes

  1. Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52

    Time frame: Baseline, Week 52

    Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.

Secondary outcomes

  1. Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee

    Time frame: Week 52

    A "structural progressor" was defined as a participant who had an 8% cartilage loss in cMTFC. Number of participants who met the criteria of "structural progressor" at Week 52 are provided.

  2. Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score and Subscales Scores for Pain, Function, and Stiffness to Week 52

    Time frame: Baseline, Week 52

    Western Ontario and McMaster Universities Osteoarthritis Index is a questionnaire designed to assess health status and health outcomes in participants with OA of the knee. The questionnaire contains 24 questions targeting areas of pain, stiffness, and physical function. Pain subscale includes 5 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-20 with higher scores indicating worse symptoms and function. Stiffness subscale includes 2 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-8 with higher scores indicating worse symptoms and function. Physical function subscale includes 17 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-68 with higher scores indicating worse symptoms and function. The total score is the sum of all subscales (range: 0 to 96) with higher scores indicating worse symptoms and function.

  3. Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52

    Time frame: Baseline, Week 52

    The participant was asked "how would you rate the pain felt in the selected knee within the last 48 hours?". The participants rated the pain by marking the level of pain on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher pain intensity.

  4. Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52

    Time frame: Baseline, Week 52

    The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated the disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.

  5. Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria

    Time frame: Week 52

    OMERACT-OARSI criteria involves improvement based on WOMAC pain and function subscales and PGA. The responders according to OMERACT-OARSI criteria were participants who had:

    • A high improvement in pain or in function ≥ 50% and absolute change ≥ 20, OR
    • Improvement in at least 2 of the 3 following:
    • Pain ≥ 20% and absolute change ≥ 10
    • Function ≥ 20% and absolute change ≥ 10
    • Patient's global assessment ≥ 20% and absolute change ≥ 10.

    WOMAC pain subscale score: range of 0 to 20, higher scores indicating more pain,

    WOMAC physical function subscale score: range of 0 to 68, higher scores indicating worse physical function),

    PGA: The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.

  6. Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52

    Time frame: Baseline, Week 52

    Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI.

  7. Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28

    Time frame: Baseline, Week 28

  8. Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52

    Time frame: Baseline, Week 52

  9. Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52

    Time frame: Baseline, Week 52

    The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray.

  10. Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study

    Time frame: Baseline up to Week 52

    Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders.

  11. Plasma Concentrations of GLPG1972

    Time frame: Pre-dose at Weeks 4, 12, and 52; Pre-dose and one post-dose sample (2-4 hours interval) at Week 28; one post dose sample (interval 4-8 hours) at Week 40

  12. Number of Participants With Treatment-emergent Adverse Event (TEAE)

    Time frame: Baseline up to 2-weeks after last dose of IMP (up to Week 54)

    TEAEs were defined as all adverse events (AEs) that occurred:

    • between first IMP intake date (included) and last visit of participant, or
    • before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant.

    Number of participants with at least 1 TEAE (serious or non-serious) are reported.

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Collaborators

  • Institut de Recherches Internationales Servier

Registry information

Official study title

Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study

Acronym: Roccella

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2018
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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